In collecting and maintaining medical research records it is a goal of the records management system to avoid duplicate records for a test-subject and at the same time insure that any given record is attributable to only a single test-subject. Furthermore, a clinical research facility in one location may utilize the services of a test-subject for a particular testing regimen, and then the test-subject may move to a different location and enroll in a different clinical research study at his or her new location. With each clinical research facility typically maintaining separate medical records for testing that the provider renders, the researchers may not have access to records about the people from previous testing. Such documents may include, for example, admission records, researcher notes, lab results and test results.
Each research establishment will normally identify a test-subject with a medical record number or account number of its own choosing in order to track medical records the facility generates in connection with the test-subject. In addition, each research establishment may keep the test-subject's records in a format or arrangement that is different from the format and arrangement used by another research establishment, thereby making it difficult for one research establishment to utilize the records of another research establishment.
In setting up the rules and procedures for managing the test-subjects of the clinical research facilities, and in order to make the research results more reliable, cost effective and deliver a higher reliability of information, it may be advantageous to collect all of a test-subject's medical and research records in a central location for access by other researchers and the peripheral organizations that service them. A central database of medical and research related information about its test-subjects enables a clinical research network to determine and set practices that help to reduce costs and improve the reliability of the results it ultimately provides to the pharmaceutical companies that are its customers. Duplicate record keeping is avoided and the accuracy of the contained data is less likely to be ambiguous. Ultimately the public is the beneficiary of this effort in that the pharmaceuticals are tested more thoroughly and reliably and result in better dosing, less unknown side effects and more confidence in the medications and results. However, managing such a database would be expensive, and would require many entities cooperating in a way that is currently not practical, and in some instances not desired by the entities collecting clinical research information.
What is needed is a means by which various clinical research facilities are able to access information about other clinical research test-subjects, without each clinical research facility being compliant with a predefined set of standards. This need can be served by the use of an electronic authorization system that is highly fraud-resistant, practical, convenient for the user, and yet cost-effective to deploy. More specifically, there is a need for an electronic authentication system that relies solely on an individual's physiological features (biometric) for event or transaction authorization, and does not require the individual to directly possess any personalized man-made memory devices or physical tokens such as smart cards, magnetic swipe cards, identification cards, driver's licenses or personal computers for identification.